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The Biden administration is implementing a Trump-era proposal that enables healthcare professionals to more easily administer the opioid addiction treatment buprenorphine. Read More
For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More
U.S. prices for nearly two dozen brand-name prescription drugs in 2020 were two to four times those seen by consumers in Australia, Canada and France, said the Government Accountability Office (GAO). Read More
On May 1, revisions will go into effect on the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Principals (GMPs) Guide, addressing the manufacturing of advanced therapy medicinal products (ATMPs) in addition to biological medicinal substances and products. Read More
The FDA’s Oncologic Drugs Advisory Committee met Wednesday for its day two discussion of accelerated approvals for PD-1/L1 inhibitors that haven’t verified their benefit in confirmatory trials, recommending the agency hold off on withdrawing bladder cancer indications for Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab). Read More
President Biden in his speech to Congress this week highlighted his support of lower drug prices by proposing to allow Medicare to directly negotiate with drugmakers, echoing language in H.R. 3, which has been reintroduced in the House. Read More
An independent expert panel of the FDA voted 7-2 Tuesday to allow Roche’s Tecentriq (atezolizumab) to remain approved for treating PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) alongside nab-paclitaxel as further trial data are generated. Read More
Exela Pharma Sciences drew a warning letter from the FDA for inadequate procedures for reporting adverse events and other lapses observed during an agency inspection of its drug outsourcing facility in Lenoir, North Carolina. Read More
The European Medicines Agency (EMA) has released new guidance on the use of good manufacturing practices (GMPs) in the production of biological starting materials for advanced therapy medicinal products (ATMPs). Read More
The FDA on Friday amended its Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine to reflect the risk of rare blood clots and said vaccinations could resume immediately, based on recommendations by a Centers for Disease Control and Prevention (CDC) advisory committee. Read More